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1 Laborate Pharmaceuticals DRA Executive Job
DRA Executive
Laborate Pharmaceuticals
posted 20d ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
- Preparation & Compilation of Dossier in ACTD / CTD format as per standard guidelines of the countries
- Handling of Daily activities of D.R.A. department
- Review of Technical documents and samples for registration purpose.
- Preparation of documents as per specific requirement of the countries.
- Knowledge of legal documents and Authority's Regulatory documents such as NOC, Product Permission, COPP, FSC, Manufacturing licenses, GMP, WHO GMP etc.
- Responsible for Preparation / Reviewing of :- (i) MSDS (ii) Package Insert/PIL (iii) Drug Master File (IV) RMP
- Product Artwork checking & approval in regulatory aspects for export and maintain their records.
- Ability to work productively in a team environment with good interpersonal skills.
- Co-ordination for Technical documents and sample requirements for submission with internal departments like QC, QA, Production, Analytical Development, Micro, F & D, R&D.
- Update licensing and collect information on registration instructions and regulation.
- Evaluation of Bioequivalence and Clinical Trials (preferably).
- Having knowledge of ICH guideline
- To be flexible for travelling and meeting with manufacturing plant representatives, which located out station.
- Must have excellent communication skills
- Must have excellent in analyzing skills
- Excellent in accuracy and focus
- Self-motivated and enthusiastic
- Knowledge of Ms Office (Word, Excel, PowerPoint, Internet Applications, Email etc.)
- Job Location will be PANIPAT only (Candidate apply only if comfortable for Panipat Location)
Employment Type: Full Time, Permanent
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People are getting interviews at Laborate Pharmaceuticals through
People are getting interviews through
(based on 7 Laborate Pharmaceuticals interviews)
Job Portal
Walkin
Campus Placement
29%
28%
14%
29% candidates got the interview through other sources.
Moderate
Confidence
?
Moderate Confidence means the data is based on a sufficient number of responses received from the candidates
What DRA Executive at Laborate Pharmaceuticals are saying
DRA Executive salary at Laborate Pharmaceuticals
reported by
5
employees
with 1-3
years exp.
₹2.7
L/yr - ₹4.7
L/yr
9%
more
than the average DRA Executive Salary in India
View more details
What Laborate Pharmaceuticals employees are saying about work life
based on 176 employees
Strict timing
Monday to Saturday
No travel
Day Shift
Laborate Pharmaceuticals Benefits
View more benefits
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